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Plandai Biotechnology Inc (OTCMKTS: PLPL) Biotech Reverse Merger & FDA Approved Puriblood Leukocyte Reduction Blood Filtration System Looks to Go Public via Plandai

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Plandai Biotechnology Inc (OTCMKTS: PLPL) has been moving northbound trading over $280,000 in dollar volume and moving up 40% on Tuesday. The stock was up over 40% in the first hour of trading on Wednesday. The Company recently eliminated the rest of their debt and trades at a low $4.9 million total market valuation. Recently Plandai announced a reverse merger LOI with Puriblood Medical Co., Ltd whereby, Jessie Chiang Chiang via entities she controls, will license to Plandai the exclusive rights to the Puriblood technology for North, Central, and South America for a period of 30 years and will acquire the controlling interest in the Company and will become the Company’s Director, President, and Chief Executive Officer.  

The Puriblood Leukocyte Reduction Blood Filtration System helps ensure the quality of blood used for transfusions, by effectively removing Leukocytes from blood, thereby minimizing acute or delayed adverse transfusion reactions, including infection and death. Currently, approximately thirty countries around the world require leuko-reduction in blood supplies. Puriblood’s core blood purification filters reduce up to over 99% of leukocytes, in substantially less time, with minimal blood loss, while retaining a high level of red blood cells (where a higher number of red blood cells retained is desirable). Puriblood’s technology is patented in multiple strategic countries, including the United States, and cleared for marketing by the U.S. Food and Drug Administration under Section 510(k) of the Federal Food, Drug, and Cosmetic Act.  

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Plandai Biotechnology Inc (OTCMKTS: PLPL) a Nevada corporation, is a publicly quoted shell company seeking to create value for its shareholders by merging with another entity with experienced management and opportunities for growth. Microcapdaily reported on PLPL years ago stating at the time: “Plandai Biotechnology Inc (OTCMKTS: PLPL) The widespread euphoria has driven pot stocks sky high and PLPL was no exception the last time around. Now that the sector is heating up again the stock seems to be under accumulation.” 

In January 2022, in a private transaction, Plandai Biotechnologies, Inc. announced that its final legacy debt with EMA Financial was purchased by an accredited investor in a private transaction. EMA’s original loan of $57,500 to Plandai dated back to September 21, 2016. Plandai defaulted on the convertible note on September 21, 2017, resulting in default penalties, conversion terms and interest which were burdensome to Plandai. The private transaction assures Plandai that the debt will be resolved with a friendly long-term investor who believes in the future of the Company. 

Placing EMA Financial’s debt with a friendly accredited investor who shares managements long-term vision with the Company, helps remove an immediate financial burden on Plandai and its liquidity, and helps the Company move forward.  Plandai now has a great looking balance sheet with just $361,250 in total liabilties. 

On May 23 Plandai announced its entry into a non-binding letter of intent to enter into a new business through a proposed product and technology rights licensing agreement with the holder of rights to the unique Puriblood Leukocyte Reduction Blood Filtration System. 

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Puriblood Medical Co., Ltd. [Taipei Exchange], develops and sells blood cell separation products including its leukocyte reduction filters for red blood cells, platelets, and whole blood, as well as real-time filtration sets for whole blood. The Puriblood Leukocyte Reduction Blood Filtration System helps ensure the quality of blood used for transfusions, by effectively removing Leukocytes from blood, thereby minimizing acute or delayed adverse transfusion reactions, including infection and death. Currently, approximately thirty countries around the world require leuko-reduction in blood supplies. Puriblood’s core blood purification filters reduce up to over 99% of leukocytes, in substantially less time, with minimal blood loss, while retaining a high level of red blood cells (where a higher number of red blood cells retained is desirable). Puriblood’s technology is patented in multiple strategic countries, including the United States, and cleared for marketing by the U.S. Food and Drug Administration under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. Puriblood is a U.S. registered trademark of Puriblood Medical Co., Ltd. Corporation Taiwan 2f., No. 11, Gongye E. 9th Rd. Hsinchu County 30075 Taiwan R.O.C. 

Under the terms of the proposed agreement, the current holder of the worldwide rights, exclusive of Taiwan, Jessie Chiang, via entities she controls, will license to Plandai the exclusive rights to the Puriblood technology for North, Central, and South America for a period of 30 years. Upon closing of the proposed transaction, Ms. Chiang will acquire the controlling interest in the Company and will become the Company’s Director, President, and Chief Executive Officer. Ms. Chiang will then appoint new members to the board of directors and will move to establish a board of advisors consisting of leading industry, finance, and business experts. 

Tad Mailander, the Company’s CEO and director commented, “We have been very clear with our shareholders that Plandai has planned to create increased value by merging with another business entity or implementing a positive change in business direction via a new management team. We have been carefully vetting such opportunities, and we are now pleased to present this opportunity to our shareholders. We view this proposed transaction as being in the best interest of our shareholders. Our team is looking forward to completing our due diligence process and ultimately closing on this transaction.” 

Jessie Chiang commented: “This is an extremely exciting opportunity for the teams of our companies to all work together in synergy to maximize the potential of this frequently essential medical device in the international and domestic market.” 

The global leukapheresis market is primarily driven by solid growth in voluntary blood donations, rising incidence of hematologic diseases, such as leukemia, and an aging population in many countries. As a result, several industry analysts are forecasting continued strong growth in technologies and products designed for this market. For example, Quince Market Insights, in a report issued late in 2021, estimates the global leukapheresis market will grow at a compound annual growth rate of 43.9% until 2030. 

While the parties have agreed to non-binding terms in a letter outlining their intentions, the transaction has not yet been consummated, and there is no assurance that any such transaction will ultimately close. Plandai plans to release additional information concerning the progress of the proposed transaction as soon as possible, upon the completion of its due diligence investigation. 

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Currently trading at a $4.9 million market valuation Plandai has 7,006,411,205 shares outstanding and 5,176,257,801 shares currently in the float. They sound like big numbers but PLPL is trading at $0.0007 after going up 40% on Tuesday on about $280,000 in dollar volume. PLPL is an exciting opportunity in small caps, a clean reverse merger in the notoriously explosive biotech sector, that just eliminated their debt and trades for less than $5 million total market valuation. Recently Plandai announced a reverse merger LOI with Puriblood Medical Co., Ltd whereby, Jessie Chiang Chiang via entities she controls, will license to Plandai the exclusive rights to the Puriblood technology for North, Central, and South America for a period of 30 years and will acquire the controlling interest in the Company and will become the Company’s Director, President, and Chief Executive Officer. Puriblood’s technology is patented in multiple strategic countries, including the United States, and cleared for marketing by the U.S. Food and Drug Administration under Section 510(k) of the Federal Food, Drug, and Cosmetic Act. The Plandai / Puriblood reverse merger is one biotech that has got a lot of room to grow from current levels. Microcapdaily will be covering Plandai / Puriblood RM as it happens so make sure you subscribe to Microcapdaily right now so you don’t miss it. 

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Disclosure: we hold no position in PLPL either long or short and we have not been compensated for this article.

BioPharma

Advancing Medical Frontiers: Elutia Inc.’s(NASDAQ: ELUT) Strategic Vision in a $600 Million Market

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Elutia Inc (NASDAQ: ELUT) shares bolstered a whopping 33% today as the company recently shared that they’ve secured about $10.5 million in funding through a private investment round. If all the warrants are cashed in as part of this funding, the total could go up to $26.2 million.

Latest Changes:

Just last week, Aziyo Biologics changed its name to Elutia Inc. Following this change, Elutia made an announcement about selling its Orthobiologics business unit to Berkeley Biologics, a subsidiary of GNI Group Ltd. This move is set to bring in a substantial amount of cash, totalling up to $35 million for Elutia. This sum includes a notable upfront payment of $15 million, plus additional potential earnings of up to $20 million over five years. The deal is expected to be finalized in the fourth quarter of 2023.

This sale is a big step for Elutia, especially in the realm of drug-eluting biomatrix technology (DEB). Elutia is actively seeking approval from the FDA for their main product, CanGaroo RM. This product utilizes innovative biomatrix technology with antibiotics rifampin and minocycline (RM), providing long-term protection for cardiac pacemakers and defibrillators. This tackles a huge market estimated to be worth around 600 million. Elutia is aiming to introduce CanGaroo RM to the market in the first half of 2024.

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Standard Of Care:

Medtronic (NYSE: MDT) stands as the exclusive provider of the antibiotic envelope within the current market. This envelope is crafted using synthetic mesh infused with antibiotics. Back in 2014, Medtronic acquired this technology, making a strategic investment of up to $200 million. Primarily intended for Cardiac Implantable Electronic Device (CIED) revision procedures, this product boasts estimated annual sales in the range of $250 to $300 million.

However, despite its market presence and revenue generation, the Medtronic antibiotic envelope has notable limitations. While it effectively combats infections, its synthetic composition renders it less effective in supporting wound healing. Moreover, it poses challenges in accommodating larger devices like Subcutaneous Implantable Defibrillators (SCID).

Drug-eluting biomatrix (DEB):

Drug-eluting biomatrix (DEB) involves a specialized approach to drug delivery using a biomatrix as a carrier or platform. In simple terms, it’s a technique where a biomaterial matrix, often a biocompatible polymer or similar substance, is used to release drugs in a controlled and targeted manner.

The biomatrix acts as a support structure that can hold and gradually release drugs or therapeutic agents at a specific site in the body, typically over an extended period. This is particularly useful in medical applications where a localized and sustained delivery of medication is necessary.

For instance, in the context of Elutia’s CanGaroo RM, a biomatrix incorporating antibiotics rifampin and minocycline is used to provide prolonged protection for cardiac pacemakers and defibrillators. The biomatrix slowly releases these antibiotics at the surgical site, preventing infections and promoting healing.

DEB technology is gaining traction because it enhances treatment efficiency by ensuring the drug is delivered directly to the target area, minimizing side effects, and optimizing therapeutic outcomes. It’s a promising approach in the field of medical advancements, especially in areas like cardiology, oncology, and orthopedics.

Post-mastectomy Breast Reconstruction:

On top of this, the company also has plans to develop an RM version of its SimpliDerm biomatrix tailored for breast reconstruction procedures. The rate of infections after this surgery is quite high, more than 10%, highlighting a big medical need in a market valued at over $500 million. Elutia is stepping up to address this issue by developing SimpliDerm® RM, which incorporates their unique DEB technology. The funds raised through the private investment round (PIPE) and the sale of the Orthobiologics business unit will not only boost Elutia’s efforts in advancing their drug-eluting biomatrix products for the cardiac pacemaker and defibrillator market, but also for post-mastectomy breast reconstruction.

What’s next:

As mentioned earlier, their biomatrix platform serves two major markets. CanGaroo RM, their upcoming product, is slated for a 1H of 2024 market release and is poised to be a pioneer in a $600 million market. Furthermore, their SimpliDerm RM product utilizes the same proprietary antibiotic-eluting technology found in CanGaroo RM, which serves a 1.6B market according to their presentation deck. They aim to secure an IDE by Q4 2024, and upon achieving these milestones, they plan to venture into neurostimulator markets, particularly in pain management, to further drive their growth.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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ZyVersa Therapeutics’ (NASDAQ: ZVSA) Breakthrough: A Super Tool for Tackling Inflammation in ALS and Beyond

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ZyVersa Therapeutics (NASDAQ: ZVSA) had a spectacular day on the market, with its stock surging by almost 50% following a significant announcement about one of their promising drug candidates, IC-100. This drug is designed to combat inflammation in the context of Inflammatory Diseases, and the latest data is incredibly promising. For those who are new to this field of investment, we’ve taken the liberty of rephrasing the press release in simpler terms.

The Release:

When you’re dealing with diseases like ALS that affect your brain and nerves, shutting down the inflammasome pathway NLRP3 (a multi-protein that regulates the immune system and inflammatory signaling), is not enough.

To address this, ZyVersa is working on something called Inflammasome ASC Inhibitor IC-100. It’s like a super tool designed to block not just NLRP3 but a bunch of other inflammasome pathways too – up to 12 of them. This helps keep inflammation in check, whether it’s in the central nervous system (CNS) or other parts of the body where inflammation is causing problems.

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In a recent paper published in Frontiers in Immunology, they pointed out that focusing only on NLRP3 might not do the trick when it comes to calming CNS inflammation in ALS and similar diseases. They did experiments with cells and even used mice to back up their point. Turns out, just targeting NLRP3 didn’t stop the release of those pesky proinflammatory chemicals or the damage they were causing in the spinal cord.

The authors of the paper basically said, “Maybe we should aim to tackle multiple inflammasome pathways when it comes to diseases like ALS, where lots of inflammasomes are going haywire.”

The CEO and president at ZyVersa, Stephen C. Glover mentioned “Our research shows that to really put the brakes on inflammation driven by multiple inflammasomes, we need more than just NLRP3 inhibition.” He added that IC-100 is like a superhero in the world of inflammation control. It stops the formation of different types of inflammasomes, preventing the start of the inflammation chain reaction, and also puts a halt to something called ASC specks, which keep the inflammation going. You can dive deeper into how IC 100 works by checking out their website here.

So, in plain speak, ZyVersa is cooking up a promising solution for folks dealing with inflammation-related problems, especially those tied to the brain and nerves. They’re not just focusing on one troublemaker; they’re going after a whole gang to keep things under control.

Overall ZyVersa is a company on a mission to create groundbreaking treatments for kidney and inflammatory diseases, and IC-100 could help them in this mission.

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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Creative Medical Technology NASDAQ: CELZ) Major Breakthrough: Allogeneic Cell Line Paves the Way for Diabetes Treatment

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Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) has recently seen a substantial intraday gain of over 15% in its share price. Despite the absence of any recent news or filings, this surge could suggest significant progress in the realm of allogeneic cell therapy.

Background:

The company is known for its regenerative approaches in various medical areas, including immunotherapy, endocrinology, urology, gynecology, and orthopedics, and made a significant announcement. In the fourth quarter of 2022,They successfully developed a new allogeneic cell line called AlloStem™. AlloStem™ is derived from human perinatal tissue and includes a Master Cell Bank and a Drug Master File. Now, with FDA approval, their program, known as CELZ-201, is being used in an early clinical trial for type 1 diabetes and will continue to be developed for both type 1 and type 2 diabetes treatment.

Additionally, the company is using the AlloStem™ line for its StemSpine® procedure to help treat chronic back pain. They report remarkable results, including over a 90% reduction in narcotic usage, more than an 80% reduction in pain scores, and over a 50% reduction in the Oswestry score in patients treated with AlloStem™.

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Allogeneic Cell Therapy:

Allogeneic Cell Therapy is a treatment that uses cells from healthy donors to treat patients with otherwise untreatable diseases. These cells can come from various sources, like bone marrow, blood, or umbilical cord blood. This approach shows great promise in the medical field.

Allogeneic cell therapy offers potentially curative options for patients when traditional treatments fall short. While still a relatively new field, ongoing research into allogeneic cell therapies holds great potential for patients suffering from these diseases. Companies like Argan Inc. are also exploring the benefits of allogeneic cells.

With FDA approval and ongoing clinical trials, Creative Medical Technology’s recent developments open doors to innovative treatments that could significantly enhance the lives of those dealing with diabetes and other diseases. The global market for allogeneic cell therapy reached $255.6 million in 2022 and is expected to grow at a rate of 27.4% from 2023 to 2030, emphasizing the importance of continued research. As the company remains dedicated to medical innovation, their efforts have the potential to improve the health outcomes of people worldwide.

Latest Release:

The company recently shared key updates on its financial status and drug pipeline for Q3 2023. The biotech company, known for its regenerative medical solutions, reported being debt-free with $14.6 million in cash and $14.4 million in working capital, sufficient to cover expenses through 2024.

Their advancements in treating type 1 diabetes include FDA clearance for a groundbreaking clinical trial using CELZ-201 (AlloStem™). The company obtained Institutional Review Board approval and partnered with Syneos Health for this study. They also filed for Orphan Drug Designation to tackle brittle type 1 diabetes.

Promising results emerged from the CELZ-001 treatment for type 2 diabetes, demonstrating substantial reductions in insulin requirements with no safety concerns.

A pilot study on the StemSpine® procedure, using donor cells (AlloStem), showed impressive reductions in narcotic usage, pain scores, and improved functionality for chronic lower back pain patients.

Creative Medical Technology’s ImmCelz platform proved efficient, requiring fewer donor cells and yielding high-quality results.

They also collaborated with Greenstone Biosciences Inc. to develop a human-induced pluripotent stem cell (iPSC) pipeline, iPScelzTM, aimed at expediting drug discovery. The development of this cell line is expected to save the company two to three years in research and development time, along with associated expenses. Additionally, it will accelerate its drug discovery program by leveraging artificial intelligence.

We will update you on CELZ when more details emerge, subscribe to Microcapdaily to follow along!

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Disclosure: We have not been compensated for this article/video. MicroCap Daily is not an investment advisor; this article/video does not provide investment advice. Always do your research, make your own investment decisions, or consult with your nearest financial advisor. This article/video is not a solicitation or recommendation to buy, sell, or hold securities. This article/video is our opinion, is meant for informational and educational purposes only, and does not provide investment advice. Past performance is not indicative of future performance.

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